A Phase 4 interventional study of Dexmedetomidine Hydrochloride Group in Delirium, Postoperative Cognitive Dysfunction and Dexmedetomidine, sponsored by Sunnybrook Health Sciences Centre. Active, not recruiting at 1 site in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Sunnybrook Health Sciences Centre · Phase 4, Interventional, and Prevention
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Among 78 studies testing dexmedetomidine in Delirium — 16 open to participants now, 18 under way, 4 of them phase 3. Dexmedetomidine · Delirium.
Among the 78 studies testing dexmedetomidine in Delirium, this one is the 41st largest by planned enrollment, is one of 5 that started in 2018, is one of 35 in phase 4, reaches primary completion later than 9 of the 17 other live ones, and was the 40th registered.
933 studies on the registry are indexed under Delirium; 189 are open to participants now.
Browse Delirium studies →16 of the 78 studies testing dexmedetomidine in Delirium are open now, in 6 countries. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 60+
Bruyere Research Institute · Sites in Canada
Ages 18+
Tanta University · Sites in Egypt
Ages 21+
Tanta University · Sites in Egypt
Ages 65+
Beijing Tiantan Hospital · Sites in China
Ages 18+
By country, each count listing its studies:
Dexmedetomidine: first FDA approval 1999 (PRECEDEX), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 127 Delirium studies recruiting now, 99 (78%) set no upper age limit and 8 (6%) stop at 75 or younger; 8 take children under 18; 15 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
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78 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 10 · Phase 3 12 · Phase 4 35
First in 2004; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is below the median of 112 across 550 interventional studies indexed under Delirium.
Median enrollment 98 across the 78 interventional studies. Of the 36 that completed or were terminated, 8 (22%) have results posted.
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4 of 78 have an industry lead sponsor. The 10 most frequent:
Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Sunnybrook Health Sciences Centre has 5 studies filed under Delirium — fewer than ten, so there is no comparison to draw.
3 of the studies testing dexmedetomidine in Delirium that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06192615Phase 3Massachusetts General HospitalMinimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II) | 2027-10-31 |
| NCT04669457University of Massachusetts, WorcesterPediatric Delirium | 2027-04-05 |
| NCT07781462Alexandria UniversityIntravenous Infusion of Low Dose Ketamine Versus Dexmedetomedine for Delirium Treatment in Acute Heart Failure | 2027-09 |
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Among the 78 studies testing dexmedetomidine in Delirium, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.
Dexmedetomidine (DEX), a highly potent and selective α2-adrenoceptors (α2R) agonist used in clinical practice for sedation, analgesia, and anxiolysis, was recently shown to have beneficial effects on early cognitive changes by reducing delirium in humans.It also reduced memory impairment after surgery and isoflurane anesthesia, both in elderly mice (20-22 months) and in pups exposed to anesthesia in the early postnatal period. Importantly, co-treatment with DEX has been shown to restore learning and memory function in rats exposed to propofol in utero. Therefore, the investigators set out to investigate whether DEX has an effect on cognitive dysfunction months after surgery and whether it accelerates cognitive recovery from anesthesia and surgery.
Participants will be randomized 1:1 in permuted blocks of 4 to 8. The randomization sequence will be computer generated and stratified by 2 factors, planned procedure (CABG/CABG + valve or valve only procedure) and study site (for full multicentre trial).
In hospital outcomes include delirium (assessed twice daily post-operative day (POD) 0-10, death, hemodynamic instability requiring vasopressors, time to extubation, re-intubation (and reason), length of stay (in Cardiovascular Intensive Care Unit and total hospital), POCD, depressive symptoms between POD 4-10, post-operative complications (infection [surgical site, sepsis, pneumonia], myocardial infarction, renal replacement therapy, re-operation, cumulative opioid consumption (to POD 4), in-hospital mortality.
Post-operative outcomes include POCD (3/6/12 months), depression (3/6/12 months), mild cognitive impairment (MCI) at 3/6/12 months (defined as 1-2 standard deviations below age matched controls), persistent surgical site pain at sternotomy/thoracotomy/graft harvest site (Brief Pain Inventory, 3/6/12 months), recovery (3,6, 12 months).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive a loading dose of 1 μg/kg dexmedetomidine prior to transfer to CVICU over 20 min immediately postoperative, followed by continuous infusion of 0.1- 1.0 μg/kg/h for up to 24 hours or until patient is ready for discharge from CVICU (whichever is earlier).
Drug: Dexmedetomidine Hydrochloride Group
Standard sedation protocols will be followed at the discretion of the attending physician.
Dexmedetomidine will be initiated prior to transfer to the CVICU with loading dose of 1 ug kg-1 over approximately 20 minutes. This will be followed by an infusion at 0.1-1.0 ug kg-1h-1 in CVICU for up to 24 hours from the time DEX infusion started or until the patient is ready for discharge from the CVICU (whichever is earlier).
Also known as: Dexmedetomidine Hydrochloride
Rate of recruitment
Ability to recruit 15% a full trail sample size (90 participants)
Time frame: 12 Months
Completion of follow-up assessments
Ability to achieve 90% follow-up of administering cognitive assessment 3 months after surgery
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2018 (actual). Primary completion is estimated for Jul 2026, 95 months after the start.
Of 40 non-industry phase 4 interventional studies under Delirium, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 65. This study's planned 95 months is above that.
Counting every sponsor, half of 40 studies reached it within 44 months; a quarter within 25 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine
Sunnybrook Health Sciences Centre →